Regulations proposed nearly a year ago to improve the use of electronic health records (EHRs) remain under review by the Office of Management and Budget (OMB), delaying potential benefits for patients and clinicians alike — despite generating significant support from stakeholders and technology experts when they were introduced.
The two rules, from the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), implement elements of 2016’s 21st Century Cures Act (Cures) and are designed to help patients access more of their health data, foster the innovation of new tools to integrate into EHRs, and promote greater transparency on the safety of medical record systems.
Once finalized and implemented, these regulations will build on the near-ubiquitous adoption of EHRs—and should help fulfill the potential of these systems to improve care.
ADVERTISEMENT
Here are ways the proposed rules would promote public health and patients’ interests:
First, the rules would require that EHR systems have standard application programming interfaces (APIs), which would allow patients to see all their medical records in one place by permitting different systems to more seamlessly communicate with one another.
APIs already fuel the internet — allowing travel sites, for instance, to aggregate data from a variety of airlines and financial organizations.
Standard APIs in health care, as proposed in both the ONC and CMS rules, would let individuals download their medical records from various providers onto their smartphones and other personal devices.
Federal policies resulting from the Health Insurance Portability and Accountability Act, a 1996 law that governs access to and privacy of medical records, already give patients the right to obtain their health information in the form of their choice, whether compact disc, paper file, electronically or another format.
However, individuals often encounter bureaucratic barriers to gaining access to their records — such as fees associated with requesting paper copies.
The importance of patients having easier access to their own records is more than just protecting the right to know; when individuals can obtain their medical records electronically via APIs, they can aggregate data from multiple facilities to more actively monitor chronic conditions, better adhere to treatment plans, and find errors in their health record.
And, in fact, research has shown that access to clinical notes makes individuals more likely to follow through on tests and referrals.
These APIs also can provide tools to aid clinicians in decision-making, such as selecting the right medication based on an individual’s specific condition. For example, APIs allow hospitals to integrate clinical decision support tools from third-party technology companies that offer insights that an EHR might not — just as smartphone users download apps that may provide better mapping, financial, or email services than those provided by the phone’s developer.
APIs could usher in that same type of open marketplace, giving hospitals and clinicians access to innovative tools to improve patient care.
The rules also encourage health care providers to communicate with one another to coordinate care for patients. ONC’s regulations would ban hospitals and EHR developers from restricting access to patient data for their own business reasons — such as not wanting to share information with a competitor. Organizations that fail to share data when requested by, or in the best interest of, the patient can face stiff fines.
Meanwhile, CMS’ proposed rule would require hospitals to notify a patient’s doctors when the individual is admitted to or discharged from the hospital, letting clinicians ensure that patients obtain appropriate follow-up care. One study found that patients whose doctors received such notifications were less likely to be readmitted to the hospital within 30 days of discharge.
Finally, ONC’s rule would eliminate so-called gag clauses in EHR vendor contracts and instead would give health care providers the ability to share screenshots of their systems with one another. That information could help hospitals and EHR developers collaborate to improve system designs and address issues — such as confusing screen layouts — that may contribute to medical errors.
One study of medication errors in selected hospitals found that system usability — which refers to how clinicians interact with the technology and are affected by system design and site-specific customizations — contributed to nearly two-thirds of the safety events researchers examined. Sharing screenshots could help address and prevent those issues.
Despite the public health benefits of the proposed regulations, they won’t resolve all the challenges with the implementation and use of health information technology.
However, taken as a whole, they make important and substantive changes that should improve health care delivery. Once the regulations are finalized, government, patients, health care organizations, and EHR developers should then continue working to address gaps in the use of health information technology, including how to protect patient privacy as individuals download their records; further accelerate communication among health care providers; and enhance the safe use of EHRs.
Some opportunities are on the horizon: CMS has indicated that it is drafting another rule on health data exchange, while ONC must still issue policies implementing other provisions from Cures, including the development of a publicly accessible website that lists information on the functions of different EHRs.
Congress gave the executive branch clear directives in Cures: to offer patients and clinicians better information to guide care decisions and address limitations in the design of EHRs. As proposed, the CMS and ONC rules would be a major step forward, enabling patients to gather their records, clinicians to share data, and health care providers to utilize more advanced tools to offer safe, high-quality care. OMB should end the delays and finalize the rules; Congress should then support the rapid implementation of the rules so that patients, and public health writ large, can reap the benefits.
Ben Moscovitch directs The Pew Charitable Trusts’ health information technology initiative.